DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 08/23/2025 has been entered:
Claim 1 – 8 remain pending in the application;
Claim 1, 2 and 8 are amended;
Claim 9 – 21 are cancelled.
Applicant’s amendments to claim overcome each and every claim objection as set forth in the Non-Final Office Action mailed on 02/24/2025. The corresponding claim objections are withdrawn.
Applicant does not need to submit Specification and Abstract again in future response if there is no amendment to specification.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim 1 – 8 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Regarding the rejection of independent claim 1, applicant submitted on p.1 that “In the Farley disclosure, the detailed description of Figure 9A as it does not describe or illustrate the guide, which aims fixing device 906 and is removably attached the nail, to target the distal hole in IM nail 902. The guide only describes targeting the proximal hole (nearest to the femoral head). This is done to only illustrate the location of the navigation fiducial landmarks necessary for classical surgical navigation. Secondly, Farley teaches a method of distal fixation which combines two systems which add to both the cost of the total targeting system but also adds unnecessary error to the targeting step. The positional error in the of the distal hole on IM nail 902 is a sum of the error of the optical navigation system and the error of the shape-sensing optical fiber. Farley effectively teaches away from Dell’Oca as the distal targeting taught by Farley, published in 2023, employing a combination of position tracking systems, is unnecessary in light of Dell’Oca which was published far earlier in 2011.” Applicant’s arguments have been fully considered but they are not persuasive for the following reasons.
First, the Fig.9A of Farley is not cited to teach the removable attachment feature and the distal hole targeting feature (see p.6 of Non-Final Office Action mailed on 02/24/2025). It provides a base for modification. The Fig.9A shows a typical interface for connecting additional element on the device. Bothe Farley and Dell’Oca teaches an apparatus for bone nail distal hole fixation, they are solving same problem and have similar base structures. Farley does not teach away from Dell’Oca.
Second, even though Farley teaches using additional optical tracking device, there is no such teaching or suggestion about the summation of error for using extra tracking mechanism. Dell’Oca does not prevent using either technic for tracking or aiming the position.
Thus, applicant’s arguments regarding the rejection of independent claim 1 have been fully considered but they are not persuasive.
Regarding the rejection of dependent claim 5, applicant submitted on p.1 – 2 “that the calibration step taught by Ramamurthy is substantively different in method and purpose. This is a critical difference in that the calibration in the present invention is initializing the position of drill guide 813 to be aligned with its target, hole 501a, when nail 502a is in its initial, unflexed state and the first position of target node 603 is recorded. The present invention does not use Stage 1615 of Ramamurthy, as there are no ‘known geometric configurations” needed. Calibration procedure 1600 is used to verify that the shape being sensed matches a known shape. Since the purpose, method, and necessity of the calibration of the present inventions is different than what is described in Ramamurthy, Claim 5 should not be rejected as prima facie obvious.” Applicant’s arguments have been fully considered but they are not persuasive for the following reasons.
First, claim 5 recites “further comprising a calibration file containing calibration information relating the pose of the second node with respect to the first node in the coordinate system to the pose of the at least one target feature with respect to the first device end, wherein the calibration file is provided as digital information accessible by the data processing system.” The claim only requires a calibration relationship between pose of node to the corresponding target feature. There is no requirement when and how such pose should be. Applicant’s arguments are not positively recited in the claim and therefore do not have patentability weight.
Second, the claimed invention as recited above does not prevent using known geometry. And the additional stage 1615 in Ramamurthy does not affect the calibration file with all features as claimed.
Thus, applicant’s arguments regarding the rejection of dependent claim 5 have been fully considered but they are not persuasive.
Regarding the rejection of all other corresponding dependent claims, applicant’s remarks submitted on p.1 rely on supposed deficiencies with the rejection of parent claim 1. Applicant’s arguments are not persuasive for the same reasons detailed above.
Overall, applicant’s remarks submitted on p.6 – 7 have been fully considered, but they are not persuasive. THIS ACTION IS MADE FINAL.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 – 4 and 6 – 8 are rejected under 35 U.S.C. 103 as being unpatentable over Farley et al. (US 2023/0414293 A1; priority date on 12/09/2020) (hereinafter "Farley") in view of Dell'Oca et al. (US 2011/0184477 A1; published on 07/28/2011) (hereinafter "Dell'Oca").
Regarding claim 1, Farley teaches a system for targeting a feature on a surgical device ("The non-invasive patient tracking system comprises one or more optical fiber cables … further cause the processor to determine, based on the locational data and the fiber optic shape, a location of the surgical tool." [0021]), comprising:
a shape sensing element having a first element end and a second element end and a plurality of nodes dispersed therebetween ("The one or more optical fiber cables comprising a first end and a second end, wherein the second end is a known distance from the tip end." [0030]; "Each of optical fibers 304 can include any number of FBGs 110." [0080]; see Fig.1 and 2 for the nodes of sensors), the first element end coupled to an interrogator ("The fiber optic tracking system additionally comprising at least one optical interrogator optically coupled to the first end …" [0030]), wherein the shape sensing element is configured to receive an interrogation signal from the interrogator and return a modified signal to the interrogator ("… the multi-core fiber optic cable 100 terminates at an interrogator that reads changes in the light wavelengths (e.g., resulting from the FBG sensors 110, or the like)." [0080]; "During use, a source light signal 914 can be transmitted to the fiber core 912 while return light signal 916 is received from fiber core 912." [0108]; this is also the inherent property of any FBG interrogation.) related to the pose of the nodes in a coordinate system ("A probe including an FBG can be inserted either into the cannulation of the IM nail 902 or a small bore (e.g., a machined recess, or the like) located within the wall of the implant and used to detect deflection of the IM nail 902 in situ. As such, distal hole-targeting for the placement of IM nail 902 can be facilitated with surgical navigation techniques." [0108]; see Fig.2 the global coordinates and the FBG coordinates), wherein a first node is coupled in communication with a first device end (see Fig.2, the most left sensor) and a second node is coupled in communication with at least one target feature on the surgical device (see Fig.2; Fig 9B), wherein the surgical device comprises the first device end and a second device end and the at least one target feature located therebetween ("As IM nail 902 is inserted into the medullary canal of bone 904, IM nail 902 will deflect." [0109]; see Fig.9A and 9B, the holes on probe 910 for locking screw are interpreted as the target feature); and
a data processing system configured to interpret the modified signal to determine the position and orientation of the nodes in the coordinate system ("The fiber optic tracking system additionally comprising at least one optical interrogator optically coupled to the first end, a processor, and a non-transitory, processor-readable storage medium that stores instructions executable by the processor. The instructions, when executed by the processor, cause the processor to obtain, from the optical interrogator, indications of a fiber optic shape associated with each of the one or more optical fiber cables and determine, based on the fiber optic shape and the known distance, a location of the tip end." [0030]), and provide to a user adjustment information related to a change in pose of the at least one feature with respect to the first device end ("… such as tracking and targeting screw holes in implants for drilling procedures … for distal screw hole targeting of an intramedullary (IM) rod, also referred to as an IM nail by accounting for the deflection of the implant in 6DoF." [0107]),
wherein a change in pose of the second node with respect to the first node is related to the change in pose of the at least one feature with respect to the first device end ("The deflection of IM nail 902 can be measured and/or determined based on return light signal 916 assisting with entry portal acquisition. FIG. 9C depicts a portion of fiber core 912 in a deflected state. As can be seen, as the fiber core 912 moves in either a bending motion or a twisting (e.g., torsional) motion, the amount of bending or twisting can be determined from the return light signal 916." [0109]),
wherein a guide system is coupled to the first device end (see Fig.9A, the element holding locking screw 906, and the interface for coupling additional element).
Although Farley does not explicitly teach the guide system and the guide aperture are coupled in a removable manner, such configuration is very typical in the bone nail and targeting system.
In addition, in the same field of endeavor, Dell’Oca teaches wherein a guide system is removably coupled to the first device end ("The distal portion 4′ of the aiming arm 4 is connected to the proximal end 1″ of the nail 1 by, for example, a set screw 5." [0026]; here the aiming arm 4 is the equivalent part of the locking screw 906 holding part as taught by Farley),
wherein the guide system comprises a guide aperture having a first guide end and a second guide end and a guide axis therebetween ("The proximal portion 4″ of the aiming arm 4 has a transverse distal hole 8 extending therethrough which, when the proximal and distal portions 4″, 4′, respectively, have been properly positioned relative to one another, extends along the axis 10." [0026]), the guide aperture being moveable with respect to the first device end ("For example, before insertion into the body, the aiming arm 4 may be coupled to the nail 1 and the orientation of the proximal portion 4″ relative to the distal portion 4′ may be adjusted ..." [0027]) and configured to pass a surgical tool along the guide axis ("A pointer member such as a wire or a pin 12 is then slid through the sleeve 11 to contact the femur 2 …" [0026]),
wherein the adjustment information is related to a change in pose of the guide aperture with respect to the first device end aligning the guide axis with the at least one target feature ("As seen clearly in FIG. 5, the line 13 does not pass through the hole 9. This is the result of deformation of the nail 1 during insertion which bent the distal portion 1′ out of its initial orientation relative to the proximal portion 1″." [0027]; "As shown in FIG. 6, the knob 7 may then be loosened and the proximal portion 4″ of the aiming arm 4 may be repositioned relative to the distal portion 4′ until the line 13 on the X-ray image is moved to pass through the center of the hole 9 in the image." [0028]; the deformation of nail as shown in image is the adjustment information).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the distal targeting device as taught by Farley with the movable aiming arm as taught by Dell'Oca. By providing nail deformation information from FBGs as taught by Farley, it would be helpful to adjust the aiming arm for "shortening the time required to perform the procedure" (see Dell'Oca; [0011]).
Regarding claim 2, Farley in view of Dell’Oca teaches all claim limitations, as applied in claim 1, and Farley further teaches wherein the shape sensing element comprises at least one optical fiber ("FIG. 9B depicts a probe 910 with a fiber core 912 that can be inserted into IM nail 902. Fiber core 912 includes one or more FBG 918." [0108]), wherein the at least one optical fiber comprises at least one core ("The main configurations of FBGs-based shape sensors can be grouped into multiple single-core fibers, and multicore fibers (MCFs), having several cores integrated into a single fiber." [0073]), wherein the at least one core is configured to conduct the interrogation signal and the modified signal therethrough ("During use, a source light signal 914 can be transmitted to the fiber core 912 while return light signal 916 is received from fiber core 912." [0108]), wherein the interrogation signal comprises at least one wavelength of light ("A fiber optic Bragg grating (FBG) is a short segment of optical fiber that reflects particular wavelengths of light and transmits others." [0008]).
Regarding claim 3, Farley in view of Dell’Oca teaches all claim limitations, as applied in claim 1, and Farley further teaches wherein the shape sensing element is removably coupled in communication with the surgical device ("A probe including an FBG can be inserted either into the cannulation of the IM nail 902 or a small bore (e.g., a machined recess, or the like) located within the wall of the implant and used to detect deflection of the IM nail 902 in situ." [0108]).
Regarding claim 4, Farley in view of Dell’Oca teaches all claim limitations, as applied in claim 1, and Farley further teaches wherein the shape sensing element is removably coupled to the interrogator ("Multi-core fiber optic cable 100 also includes a coupler 116 …" [0070]; "Coupler 116 is arranged to couple multi-core fiber optic cable 100 to a surgical navigation system (e.g., FIG. 8 , or the like) to provide optical communication between the optical fibers of multi-core fiber optic cable 100 and a signal generator." [0071]).
Regarding claim 6, Farley in view of Dell’Oca teaches all claim limitations, as applied in claim 1, and Farley further teaches wherein the surgical device is an intramedullary nail ("… for distal screw hole targeting of an intramedullary (IM) rod, also referred to as an IM nail by accounting for the deflection of the implant in 6DoF." [0107]).
Regarding claim 7, Farley in view of Dell’Oca teaches all claim limitations, as applied in claim 1, and Farley further teaches wherein information related to the modified signal is provided to the data processing system via a wireless data transmission system ("Computing system 814 is communicatively coupled (e.g., via wired connection, via wireless connection, or the like) to both display 812 and signal generator and receiver 802." [0103]).
Regarding claim 8, Farley in view of Dell’Oca teaches all claim limitations, as applied in claim 1, and Farley further teaches wherein the adjustment information is provided to a display via a wireless data transmission system ("Computing system 814 is communicatively coupled (e.g., via wired connection, via wireless connection, or the like) to both display 812 and signal generator and receiver 802." [0103]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Farley in view of Dell’Oca, as applied in claim 1, and further in view of Ramamurthy et al. (US 2009/0137952 A1; published on 05/28/2009) (hereinafter "Ramamurthy").
Regarding claim 5, Farley in view of Dell’Oca teaches all claim limitations, as applied in claim 1, except a calibration file containing calibration information relating the pose of the second node with respect to the first node in the coordinate system to the pose of the at least one target feature with respect to the first device end, wherein the calibration file is provided as digital information accessible by the data processing system.
However, in the same field of endeavor, Ramamurthy teaches a calibration file containing calibration information relating the pose of the second node with respect to the first node in the coordinate system to the pose of the at least one target feature with respect to the first device end ("At stage 1610, a sensed geometric configuration is determined based on signals or light 326 received from the one or more Bragg gratings 302 of a fiber sensor 215 while the instrument body 210 is in the known geometric configuration ... At stage 1620, if necessary, data representative of the comparison is stored on a storage medium associated with instrument 210." [0140]; "The types of information that can be stored ... a position of fibers 215 within or coupled to an elongate instrument 210 or other system component, a position of each FBG 302 formed within the core 304 ..." [0142]), wherein the calibration file is provided as digital information accessible by the data processing system ("… is stored on a storage medium associated with instrument 210. The storage medium may be, for example, a programmable device … in which case retrieval can be performed via a computer network." [0140]; information stored and retrieved in computer is in digital format).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the optical shape sensing as taught by Farley with the calibration process as taught by Ramamurthy. By using calibration, "the sensed position and/or orientation variables are adjusted based on calibration data" (see Ramamurthy; [0141]), in which "any error may be calibrated out" (see Ramamurthy; [0144]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHAO SHENG whose telephone number is (571)272-8059. The examiner can normally be reached Monday to Friday, 8:30 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M. Kozak can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797